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Brief Title: Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Participants With Hematological Malignancies
Official Title: A Phase 1b Trial of Magrolimab Monotherapy or Magrolimab in Combination With Azacitidine in Patients With Hematological Malignancies
Study ID: NCT03248479
Brief Summary: The primary objectives of this study are: * To confirm the safety and tolerability of magrolimab monotherapy in a relapsed/refractory (R/R) acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) population, and of magrolimab in combination with azacitidine in previously untreated participants with AML or MDS and participants with R/R AML and MDS * To evaluate the efficacy of magrolimab monotherapy in R/R AML/MDS, and of magrolimab in combination with azacitidine in previously untreated participants with AML/MDS, or R/R AML/MDS as measured by complete remission (CR) rate for participants with AML and higher-risk MDS, and duration of complete response for participants with AML and higher-risk MDS, and duration of CR for participants with AML and higher-risk MDS * To evaluate the safety, tolerability, and efficacy of magrolimab monotherapy or combination with azacitidine in low-risk MDS participants as measured by red blood cell (RBC) transfusion independence rate
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope National Medical Center, Duarte, California, United States
University of California San Diego (UCSD), La Jolla, California, United States
UCLA Clinical and Translational Research Center (CTRC), Los Angeles, California, United States
Chao Family Comprehensive Cancer Center - UC Irvine Medical Center, Orange, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Stanford University Medical Center, Stanford, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
University Of Miami - Miller School Of Medicine, Sylvester Comprehensive Cancer Center, Miami, Florida, United States
H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida, United States
The University of Chicago, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute/ Boston Children's Hospital, Boston, Massachusetts, United States
Mid America Division, Inc., Kansas City, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Weill Cornell Medical College - New York-Presbyterian Hospital, New York, New York, United States
Icahn School of Medicine at Mount Sinai, New York, New York, United States
Herbert Irving Comprehensive Cancer Center-Columbia University Medical Center, New York, New York, United States
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University Medical Center, Columbus, Ohio, United States
Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
Tennesssee Oncology - Centennial Clinic Location, Nashville, Tennessee, United States
Texas Oncology - Baylor Charles A. Simmons Cancer Center, Dallas, Texas, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Medical College of WI Froedtert Hospital, Milwaukee, Wisconsin, United States
Oxford Centre for Respiratory Medicine Churchill Hospital, Oxford University Hospitals NHS Trust, Oxford, , United Kingdom
Name: Gilead Study Director
Affiliation: Gilead Sciences
Role: STUDY_DIRECTOR